Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

Coronary Artery Disease Clinical Trial

Official title:

Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03755700
• Other study ID #: Intervention-01
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: Yousef Rezaei, MD
• Phone: +98 91 2623 1864
• Email: yousefrezaei1986[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).

Description:

Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold.

All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients.

Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients aged =18 years with baseline estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention [PCI]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .

Exclusion Criteria:

acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction <30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Kidney Injury
• Angina, Stable
• Contrast-induced Nephropathy
• Coronary Artery Angiography
• Coronary Artery Disease
• Coronary Catheterization
• Coronary Disease
• Myocardial Ischemia
• Stable Angina

Intervention

Drug:
• Vitamin E
As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
• N-acetyl cysteine
As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
• Placebo oral capsule
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
• Placebos
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
• Normal Saline Flush, 0.9% Injectable Solution
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaie cardiovascular medical and research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Rezaei Y, Hemilä H. Vitamins E and C May Differ in Their Effect on Contrast-Induced Acute Kidney Injury. Am J Kidney Dis. 2017 May;69(5):708-709. doi: 10.1053/j.ajkd.2016.12.022. Epub 2017 Mar 6. — View Citation

Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced acute kidney injury	Contrast-induced acute kidney injury defined as an absolute increase =0.5 mg/dL or a relative increase =25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.	48 to 72 hours after coronary catheterization
Secondary	Changes in the levels of serum creatinine	Changes in serum creatinine after coronary artery catheterization	48-72 hours post-procedure
Secondary	eGFR within 48-72 hours after coronary catheterization	Changes in eGFR after coronary artery catheterization	48-72 hours post-procedure
Secondary	Changes in complete blood cell count components from baseline to follow-up	Changes in complete blood cell count components after coronary artery catheterization	48-72 hours post-procedure
Secondary	Length of hospital stay	Length of hospital stay	48-72 hours post-procedure
Secondary	Requirement for renal replacement therapies	Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation	48-72 hours post-procedure
Secondary	Post-procedure acute coronary syndrome (ACS) events	Recurrent acute coronary syndrome after coronary artery catheterization	48-72 hours post-procedure
Secondary	Post-procedure cerebrovascular events	Cerebrovascular events after coronary artery catheterization	48-72 hours post-procedure
Secondary	In-hospital mortality	In-hospital mortality after coronary artery catheterization	48-72 hours post-procedure
Secondary	Post-procedure atrial fibrillation	Atrial fibrillation after coronary artery catheterization	48-72 hours post-procedure
Secondary	Post-procedure bleeding	Bleeding events after coronary artery catheterization	48-72 hours post-procedure
Secondary	Pulmonary embolism	Pulmonary embolism after coronary artery catheterization	48-72 hours post-procedure
Secondary	Re-intervention	Repeated coronary artery catheterization	48-72 hours post-procedure